LAUSR

Objectives Drug treatment of children is often limited to liquid formulations or manipulation of adult solid oral dosage forms because of the lack of age-appropriate formulations, concerns around particle aspiration and paediatric acceptability. Recent research revealed that the administration of mini-tablets has substantial advantages in improving dose accuracy and avoiding issues related to drug stability, storage conditions, potentially toxic excipients and taste masking (especially effective when the mini-tablets are coated). Most trials were performed with single and multiple uncoated mini-tablets. This study here aimed to investigate young children’s acceptability and swallowability of multiple coated placebo mini-tablets compared with glucose syrup. Design This clinical trial was conducted as a single-centre randomised cross-over study. Setting Prospective cross-over study performed at the Children′s University Hospital Düsseldorf. Patients This study was conducted on 50 children in five age groups from 1 to <6 years. Interventions An age-adapted amount of 16–28 mini-tablets and 3–6 mL syrup was administered in randomised order. Main outcome measures Acceptability and swallowability of multiple coated mini-tablets and syrup. Results In all age groups, administration of multiple coated mini-tablets and syrup showed good acceptability (mini-tablets 80%–100%, syrup 90%–100%) and swallowability (mini-tablets 30%–70%, syrup 20%–80%) without any clinically meaningful difference. This is consistent with results from large studies with uncoated mini-tablets. Conclusion Multiple coated mini-tablets are a suitable age-appropriate alternative to liquid formulations in the paediatric population. No safety concerns with the use of coated mini-tablets were observed in the study. Trial registration number DRKS00010395.